Urine Gene Analysis for Pathogen Detection

Sponsor

David Sheyn (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05591911

Collaborator

Vikor Scientific (Other), Thermo Fisher Scientific, Inc (Industry)

100

Enrollment

7.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The objective of this study is the detection, quantification, and resistance gene identification of pathogens by using the urine of patients with urinary tract infection (UTI) symptoms.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Diagnostic Test: Urine PCR testing

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Urine Gene Analysis for Pathogen Detection, and Resistance Gene Identification for the Urinary Tract Infection Diagnosis

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients over 60 years old presenting with acute urinary tract infection symptoms	Diagnostic Test: Urine PCR testing The urine PCR panel will be performed to evaluate the bacterial growth in the patient's urine who is admitted with acute urinary tract symptoms.

Arm

Intervention/Treatment

Patients over 60 years old presenting with acute urinary tract infection symptoms

Diagnostic Test: Urine PCR testing

The urine PCR panel will be performed to evaluate the bacterial growth in the patient's urine who is admitted with acute urinary tract symptoms.

Outcome Measures

Primary Outcome Measures

Time in hours from patient presentation to optimal antibiotic prescription [Up to 30 days]
Time in hours from patient presentation to optimal antibiotic prescription will be evaluated both for urine culture and urine PCR panel utilization.

Secondary Outcome Measures

Antibiotic costs as measured by prescription records [Up to 30 days]
Antibiotic costs spent for UTI treatment will be calculated.
Number of patients with antibiotic change as measured by prescription records [Up to 30 days]
In cases where the UTI cannot be treated with the first antibiotic, other antibiotics used for this purpose will be recorded.
Duration of antibiotic usage as measured by prescription records [Up to 30 days]
Antibiotic usage duration will be recorded.
Number of any HCP visits for same issue as measured by patients reports/medical records [Up to 30 days]
Any visit to HCP for the same issue will be evaluated
Number of hospitalization related to UTI as measured by patients reports/medical records [Up to 30 days]
Hospitalization related to UTI will be recorded.
Number of additional diagnostic procedures completed in relation to UTI as measured by patients reports/medical records [Up to 30 days]
Additional diagnostic procedures completed in relation to UTI will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult men and women 60 years and older who have urinary tract infection
Can participate in the informed consent process
Presenting to the clinic with symptoms of UTI or cystitis with no recent history of UTI within the past 21 days
Able to provide sufficient urine sample volume via clean catch or catheterization for urinalysis, conventional urine culture, and PCR
Understand and are willing to comply with the study requirements.
Sample collection able to be sent out the same day via courier